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BS EN ISO 16140-3:2021 Microbiology of the food chain. Method validation - Protocol for the verification of reference methods and validated alternative methods in a single laboratory >
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BS EN ISO 16140-3:2021 Microbiology of the food chain. Method validation - Protocol for the verification of reference methods and validated alternative methods in a single laboratory, 2021
- National foreword
- European foreword
- Endorsement notice
- Foreword
- Introduction
- 1 Scope
- 2 Normative references
- 3 Terms and definitions
- 4 General principles of verification of qualitative (detection) methods and quantification methods
- 4.1 General
- 4.2 Implementation verification
- 4.3 (Food) item verification
- 4.4 Requirements for implementation verification and (food) item verification
- 4.5 Performance characteristics
- 5 Qualitative methods — Technical protocol for verification
- 5.1 Estimated LOD50 (eLOD50) determination
- 5.2 Experimental design
- 5.3 Selection of (food) items
- 5.4 Artificial contamination
- 5.4.1 Selection of strains
- 5.4.2 Inoculation of the test portions
- 5.5 Evaluation of results
- 5.5.1 Determination of eLOD50 using protocol 1
- 5.5.2 Determination of eLOD50 using protocol 2
- 5.5.3 Use of protocol 3
- 5.6 Acceptability limits
- 5.7 Root cause analysis
- 6 Quantitative methods — Technical protocol for verification
- 6.1 Intralaboratory reproducibility standard deviation determination
- 6.1.1 General
- 6.1.2 Experimental design
- 6.1.3 Selection of the (food) item
- 6.1.4 Natural contamination
- 6.1.5 Artificial contamination
- 6.1.6 Evaluation of results
- 6.1.7 Acceptability limit
- 6.1.8 Root cause analysis
- 6.2 Estimated bias (eBias) determination
- 6.2.1 General
- 6.2.2 Experimental design
- 6.2.3 Selection of (food) items
- 6.2.4 Artificial contamination
- 6.2.5 Evaluation of results
- 6.2.6 Acceptability limit
- 6.2.7 Root cause analysis
- 7 Validated alternative confirmation and typing methods — Technical protocol for verification
- 7.1 General
- 7.2 Implementation verification
- 7.3 Experimental design
- 7.3.1 General
- 7.3.2 Strain selection
- 7.4 Evaluation of results
- 7.5 Acceptability limit
- 7.6 Root cause analysis
- 8 Summary of acceptability limits for the verification of validated methods
- Annex A (informative) Classification of (food) categories and suggested target combinations for verification studies
- Annex B (informative) Guidance on how to choose challenging (food) item(s) for (food) item verification
- Annex C (informative) Qualitative method verification — Example
- Annex D (informative) Quantitative method verification — Example
- Annex E (informative) Validated alternative confirmation or typing method verification — Examples
- Annex F (normative) Protocol for the verification of non-validated reference methods in a single laboratory
- Bibliography
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